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Re: Atom0aks post# 208887

Wednesday, 08/14/2019 4:13:58 PM

Wednesday, August 14, 2019 4:13:58 PM

Post# of 426436
No those are just guidelines. There have been many recent AdComs where the announcement went out as much as three months before the AdCom...

Here's an example:

https://www.federalregister.gov/documents/2019/06/24/2019-13354/allergenic-products-advisory-committee-notice-of-meeting

They posted formal notice on June 24 of a Sept 13 meeting (almost 3 months).

They told the company on May 16.

http://ir.aimmune.com/news-releases/news-release-details/aimmune-announces-us-fda-advisory-committee-meeting-date-ar101

Obviously Aimmune either wasn't told to hold off releasing the info, or they ignored the FDA like AMRN did.

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